Apple introduced its ResearchKit, a new software platform for patient recruitment, at its “Spring Forward” event last week. It features 5 apps – asthma, Parkinson’s disease, diabetes, breast cancer, and cardiovascular disease. As one of the hundreds of millions of iPhone users, and a member of the clinical research community, I was eager to check them out.
The Potential
Anyone who works in clinical research is familiar with the common problems associated with patient recruitment, contributing to extended study timelines and increased cost. So, the prospect of an open-source app for patient recruitment is exciting. Could this deliver a truly patient-centric model, bringing the study to the patient’s handheld device? Let’s look at the promise:
Rapid Recruitment: With so many of us using Apple devices, the patient pool for clinical trial recruitment is vast. Think of the potential to recruit populations for studies that investigate chronic, widespread diseases, or, recruiting study participants from remote areas of the country. It was reported that more than 11,000 volunteers signed up for a cardiovascular trial using the MyHeart Counts app within a day after the launch of ResearchKit.
User-Friendly Functionality: Apple has built its empire on its user-friendly interface. And when you open one of the 5 apps you will see that the functionality, and the language that describes the study, is easy to follow. There are familiar prompts to learn about the study, pre-qualify and consent to it, as well as images and video to aid user comprehension.
The Risk
This shiny new Apple appears to have some brown spots, however. As with any new technology or innovation, there can be undesirable consequences.
Data Integrity: One of the challenges ResearchKit intends to overcome is the burden of data collection. Unfortunately, even in the pre-screening process, there’s a risk of gathering data from patients that is inaccurate. For example, users can enter and then change their answers to the study pre-qualifying questions, or submit their answers multiple times. Not to mention the risk of users falsifying data intentionally, with no live person to verify it.
Informed Consent: The ResearchKit apps are user-friendly. Maybe too user-friendly. The consent process educates the prospective participant about the study, using images and videos, depending on the app. Then the user takes a test to quiz their knowledge before they consent. The patient-doctor dialogue – the essence of informed consent – is removed.
Population Bias: These apps are free and easy to download. And with more than 60% of teens in the U.S. with iPhones, it opens the door to users under age 18 “qualifying” for a study. As well, market research suggests that iPhone users tend to be more affluent.
Protecting PHI: Apple expressed its commitment to user privacy, but acknowledged, “we can’t promise perfect anonymity”. Data shared using an app are not subject to the data privacy laws we’re all familiar with for clinical studies. And while Apple maintains that the personal health data collected through these apps will be de-identified, there’s always a risk that someone could re-identify it…or hack it.
The ResearchKit is an exciting development, but it’s an evolving technology. Stay tuned…the full service goes live next month.
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